The Effects of Mycophenolate Mofetil (MMF) on Renal Outcomes in Advanced Immunoglobulin A (IgA) Nephropathy Patients

Fan Fan Hou238 enrolled

Overview

The study is to evaluate the effect of Mycophenolate Mofetil compared with losartan alone on time to doubling of serum creatinine or the onset of end stage renal disease in patients with advanced IgA nephropathy who are treated with the maximal tolerated daily dose of losartan.The study will also assess the effects of MMF compared with losartan alone on the changes of urine albumin excretion and the changes in estimated glomerular filtration rate.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

238

Conditions

IgA Nephropathy

Interventions

Mycophenolate mofetilDRUG

Mycophenolate mofetil 1.5g/day plus maximum tolerated labeled dose losartan

LosartanDRUG

Maximum tolerated labeled dose of Losartan

Eligibility

Sex: ALLMin age: 16 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Biopsy-proven primary IgA nephropathy with urinary proteinuria excretion over 1g/24 hour,subjects must meet 2 of the following criteria: 1. global glomerular sclerosis plus focal segmental glomerular sclerosis ratio ≥50% 2. eGFR 30 to 60 ml/min 3. Hypertension (blood pressure over 140/90 mmHg or taking antihypertensive drugs) Exclusion Criteria: 1. Secondary IgA nephropathy 2. Familial IgA nephropathy 3. Concomitant disease: cancer, infection, diabetes mellitus, connective tissue disease, abnormal liver function 4. Pregnancy or breasting 5. Inability to comply with study and follow-up procedures

Locations (3)

Nanfang Hospital Southern Medical University

Guangzhou, Guangdong, China

The Fourth People's Hospital Shenzhen

Shenzhen, Guangdong, China

The Institute of Nephrology, Guangdong Medical College

Zhanjiang, Guangdong, China

Outcomes

Primary Outcomes

To evaluate the effects of mycophenolate mofetil on a composite renal outcomes in subjects with advanced IgA nephropathy

Time to the first occurrence of a component of the composite renal endpoint: Doubling of serum creatinine or the onset of end stage renal disease (ESRD) \[needing chronic dialysis or renal transplantation or renal death\]

Time frame: 3 years

To evaluate the effects of mycophenolate mofetil on progression of CKD in subjects with advanced IgA nephropathy

A decrease in eGFR of 30% or more and to a level of less than 60 ml/min at the exit visit if the baseline eGFR was 60 ml/min or more. Or a decrease in eGFR of 50% or more at the exit visit if the baseline eGFR was less than 60 ml/min.

Time frame: 3 years

Secondary Outcomes

To evaluate the effects of mycophenolate mofetil on the changes of proteinuria in subjects with advanced IgA nephropathy

Changes of urinary protein excretion rate

Time frame: 3 years

To evaluate the effects of mycophenolate mofetil rapid progression of CKD in subjects with advanced IgA nephropathy

Time to 30% reduction in estimated glomerular filtration rate (eGFR); eGFR reduction greater than 5 ml/min/1.73m\^2/year

Time frame: 3 years

Data from ClinicalTrials.gov

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